Many useful medical devices, both therapeutic and diagnostic, are electrically powered and include electrically powered control or sensing means. These devices frequently have only a limited useful life. The limited lifetime of these devices is determined as the period during which the devices can be relied upon to perform well, after which the devices must either be replaced or serviced. Examples of limited-use therapeutic devices are electrosurgical operating instruments such as electrocautery surgical diathermies and hemostatic scalpels, endoscopic devices such as laparoscopic scissors and probes, arthroscopic operating instruments and angioplasty reaming instruments. Examples of limited-use diagnostic devices are physiologic sensors, such as those used for the measurement or monitoring of physiological and biochemical parameters, (i.e. oxygen, glucose, etc.).
Conventional methods of tracking the remaining useful lifetime of therapeutic or diagnostic equipment consists principally of recording in a ledger the number of operations in which a device has been used, or the number of times the device has been sterilized, without regard to the actual usage of the device. Such recording systems are prone to bookkeeping errors, and may either overestimate or underestimate the condition of a device.
It would therefore be desirable to provide apparatus for more accurately tracking the usage of a limited-use medical device. The ability to track device usage would provide the capability for replacing a device before it fails, a vital consideration where the device is used in critical medical applications, such as surgical operations, or monitoring critically ill patients.
Similarly, it can be extremely important to track the usage of the more durable power supply/controller/measuring apparatus where important components may have need for periodic servicing and replacement of parts; again this need is especially important where vital medical procedures are being performed, such as surgical operations or monitoring of the critically ill. A simple workable system for accomplishing the usage of tracking and data accumulation for more durable power supply/controller/measuring apparatus is not currently available.
It would therefore be desirable to provide a system for more accurately tracking the usage of, and accmulating such usage data for, more durable power supply/controller/measuring apparatus that is used with limited-use medical devices.
In additions many durable electronic instruments used in conjunction with the limited-use devices noted above, such as electronic power supplies, controllers or measuring apparatus, may be used with more than one kind of the above-mentioned limited-use devices. Frequently, the electronic modes of operation differ, for example, constant voltage versus constant current, and the appropriate levels and limits for operating parameters of the electronic instruments differ depend upon the particular limited-use device being used. Thus, the surgeon or medical technician must be knowledgeable of the operating parameters for each type of limited-use device and set the mode of operation accordingly.
Conventional arrangements provide different connection ports on the power supply/controller/measuring apparatus for different limited-use devices (such as electrosurgical scissors versus electrosurgical scalpels). Alternatively, switching means are provided on the power supply/controller/measuring apparatus to accommodate the different demands of the various limited-use devices. However, the number of available connection ports of a power supply/controller/measuring apparatus is limited and switches may not be accurately set for a wide variety of reasons. Also, it may be possible to connect a limited-use device to an incompatible power supply/controller/measuring apparatus, thereby causing damage to both items.
It would therefore be desirable to provide a system that automatically verifies compatibility of a device with the power supply/controller/measuring apparatus when the device is connected thereto, and that automatically sets the power supply/controller/measuring apparatus to the appropriate operational parameters for the connected device, without having to dial in the particular operational parameters for that device.
In view of the foregoing considerations, it would be desirable to provide therapeutic and diagnostic medical systems having a non-volatile memory device for tracking and accumulating usage data. In addition, a non-volatile memory device associated with a limited-use medical device may be used to automatically set the operational parameters (or other parametric data) for the limited-use device when the device is connected to a power supply/controller/measuring apparatus. The non-volatile memory device in the limited-use would cooperate with control logic resident in the supply/controller/measuring apparatus to perform one or more of the following functions:
identify the specific limited-use device and automatically establish its compatibility with the power supply/controller/measuring apparatus to which it is connected, prohibiting operation of those limited-use devices that are not compatible; PA1 establish the electrical mode in which the power supply/controller/measuring apparatus should be operated with the limited-use device, if more than one kind of limited-use electrical device can be used with the power supply/controller/measuring apparatus; PA1 establish the nominal electrical parameters for the particular mode selected at which the device should be operated and the limits of those electrical parameters beyond which the device should not be operated; PA1 maintain and continually update a history of critical operating parameters for the limited-use device, (e.g. cumulative number of times activated, cumulative amount of power dissipated, number of separate occasions on which device has been used, number of times device sterilized) that may be maintained as part of the limited-use device and that may be communicated to any power supply/controller/measuring apparatus with which the limited-use device can be used; PA1 maintain a schedule of limits for each of the foregoing critical operating parameters as part of each limited-use instrument which can be communicated to any power supply/controller/measuring apparatus with which the limited-use device can be operated; PA1 maintain a program of actions to be undertaken by the power supply/controller/measuring apparatus when each of the limits has been reached (such as messages to be displayed or announced, or further operation to be prohibited); and PA1 maintain a record in each power supply/controller/measuring apparatus of the history of each and all of the limited-use devices that have been used with it.